FDA UDI
In Commercial Distribution
🇺🇸 United States
VESALIUS STERILE fingerswitch handle
DI: 08034055290255
·
Model: Sterile, L=3m
·
TELEA ELECTRONIC ENGEENERING SRL
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- VESALIUS STERILE fingerswitch handle
- Primary DI
- 08034055290255
- Version / Model
- Sterile, L=3m
- Catalog Number
- 2502006
- Company Name
- TELEA ELECTRONIC ENGEENERING SRL
- Labeler DUNS
- 435331459
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 4
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- aa6e900b-c94d-4fbc-a359-532a31ab2e8a
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | General, Plastic Surgery | 878.4400 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44681 | Electrosurgical handpiece, single-use | A hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during inert gas-enhanced electrosurgery. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08034055290255 | GS1 | ||||
| Package | 8034055294598 | GS1 | double envelope | 5 | In Commercial Distribution |